CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,080 enrolled
Drug / intervention
tomosynthesis and screening mammographydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01106911
NCT01106911N/ACompleted
CompareCT.gov

Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study

University of Pittsburgh·interventional·Posted Apr 20, 2010·Updated Mar 25, 2016

In Brief

A clinical study evaluating tomosynthesis and screening mammography for Breast Abnormalities. Completed, enrolled 1,080 participants across 1 site.

Detailed Summary

The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Abnormalities
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2010
Enrollment StartMay 1, 2010
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.2 years ago

Interventions

tomosynthesis and screening mammographydevice

All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.